Label: INSTANTFOAM NON-ALCOHOL- benzalkonium chloride liquid
PARAGON AERO INSTANT- benzalkonium chloride liquid
HY5 SOAPOPULAR AERO- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 30, 2010

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride, 0.13%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to reduce bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply one shot to dry hands, rub into skin

    No rinsing required

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Propylene Glycol, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Mangnesium Chloride, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    deb

    InstantFOAM

    non-alcohol-dye and fragrance free

    hand sanitizer

    refreshing

    no water required

    use anywhere, anytime

    use everyday

    Kills 99.99% of common germs

    deb foam technology

    NSF

    Nonfood Compounds Program Listed E-3 140059

    55854-01-116

    1 Liter - 33.8 Fluid Ounces

    container label


  • INGREDIENTS AND APPEARANCE
    INSTANTFOAM NON-ALCOHOL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-058-0147 mL in 1 BOTTLE, PUMP
    2NDC:11084-058-053780 mL in 1 BOTTLE, PLASTIC
    3NDC:11084-058-121200 mL in 1 BOTTLE, PLASTIC
    4NDC:11084-058-202000 mL in 1 BOTTLE, PLASTIC
    5NDC:11084-058-271000 mL in 1 BOTTLE, PLASTIC
    6NDC:11084-058-40400 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2010
    PARAGON AERO INSTANT 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-137-271000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2010
    HY5 SOAPOPULAR AERO 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-136-271000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2010
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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